Federal judge hears arguments on Gov. Patrick's Zohydro ban

Gov Deval Patrick's ban on the painkiller Zohydro remained in place as of this morning, as US District Court Judge Rya Zobel made no ruling on a move by the pharmaceutical company Zogenix to suspend the prohibition.

BOSTON -.Gov. Deval Patrick's ban on the painkiller Zohydro remained in place as of this morning, as U.S. District Court Judge Rya Zobel made no ruling on a move by the pharmaceutical company Zogenix to suspend the prohibition.

Zogenix is arguing that because the federal Food and Drug Administration approved its hydrocodone-only painkiller, a state may not ban it from being prescribed and dispensed.

Patrick said he would lift the ban, imposed as a state of emergency was declared in response to opiate abuse levels, if the drug-maker developed a more abuse-resistant form.

“Imagine 50 states each imposing a different formulation requirement,” Zogenix attorney Stephen Hollman said during a hearing Monday at the John Joseph Moakley U.S. Courthouse. He said that would turn into a “too many cooks” situation and said the current ban hurts the company by eating into its three-year period of exclusivity for the chemical formulation.

Assistant Attorney General Jo Ann Shotwell Kaplan said Congress had preserved the rights of states to regulate drugs and said FDA approval is “not a guarantee that they get to market thereafter in every state.”

“Congress has said, 'No, we are not going to adopt a provision that preempts state drug regulation,' ” Kaplan said.

Under questioning by Zobel, Kaplan acknowledged that she had been unable to find another example of a state banning an FDA-approved drug, and said she does not believe such a case exists.

Kaplan said the Zohydro case is “unusual” because the FDA's scientific advisory panel voted 11-2 against approval of the drug and 29 attorneys general objected to its approval.

Hollman said Zohydro is a “safe and effective drug” and part of the mix of hydrocodone-based treatments that can be used to treat chronic pain. Unlike Vicodin and other hydrocodone drugs, Zohydro does not include acetaminophen. High doses of acetaminophen taken over long period of time can lead to potentially fatal liver disorders, according to Zogenix.

Kaplan argued that FDA approval is a “floor” not a “ceiling,” and Hollman agreed, with the condition that a state cannot “eviscerate the floor.”

“I will take the papers and I thank you all,” Zobel said at the end of the hearing, giving no indication on when she might issue a ruling.

After the hearing, a group of mothers approached Zogenix President Stephen Farr, saying their children had become addicted to opiates and asking for the pharmaceutical company to take steps to prevent drug abuse.

“The majority of products in the market are not tamper-proof,” Farr told the mothers, saying tamper-resistance makes drugs less effective and acknowledging there is “clearly a societal problem” around drug abuse.

The brief conversation ended as Farr was led by an associate into a small room. Later, Farr referred questions to Hollman, who declined to comment on the widespread worry that prescription opiates offer a pathway to heroin addiction.

Brigitte, a mother who declined to give her last name because of her son's legal circumstances, asked Farr to attend a group meeting with her, an invitation he did not accept in their courtroom conversation.

Brigitte told reporters her son had been given prescription pain pills at a friend's house, became addicted, and eventually switched to heroin. Her son had an overdose, and was given the emergency medication Narcan, and is now in recovery, Brigitte said.

“The fear of this happening to other parents caused me to speak out about it,” Brigitte said. She said the group she invited Farr to attend includes parents, experts in the field and addicts who have been without drugs for a considerable period of time. Speaking with reporters, Brigitte dismissed Farr's comments to her group, saying it was “the usual blah, blah,” and saying “we heard the same story when it all started up with oxycodone,” a prescription painkiller that led to widespread drug store robberies about a decade ago.